The Effect of Intensive Insulin Therapy in the Surgical Critical Care Unit

January 26, 2006 updated by: Genesys

No Outcome Benefit for the Use of Intensive Insulin Therapy in the Critically Ill General and Vascular Surgical Patient. A Randomized Prospective Trial.

We sought to determine if there is a benefit to using an insulin drip to control hyperglycemia in the surgical critical care unit for patients who undergo general and vascular surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While evidence exists for using tight glycemic control in the critically ill cardiac surgical patient, other patient populations have yet to be studied. We performed a prospective randomized trial for using intensive insulin therapy in the general and vascular critically ill surgical patient population. We will compare tight glycemic control versus conventional glycemic control to determine if there is a benefit to the normalization of blood glucose levels in this patient population

Study Type

Interventional

Enrollment

317

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Genesys Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Patients undergoing a general or vascular surgical procedure requiring admission to the surgical intensive care unit as a result of ventilatory requirement, vasopressor support, or physiologic instability

-

Exclusion Criteria:

  • Under age 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Mortality

Secondary Outcome Measures

Outcome Measure
Length of ICU Stay
Ventilatory Requirement
Vasopressor Support
Incidence of Renal Failure
Incidence of Wound Infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genesys

Collaborators

Novo Nordisk A/S

Investigators

  • Principal Investigator: Michael Kia, DO, Ascension Genesys Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

January 26, 2006

First Submitted That Met QC Criteria

January 26, 2006

First Posted (Estimate)

January 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2006

Last Update Submitted That Met QC Criteria

January 26, 2006

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRMC 050023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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